Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
Reported: February 14, 2018 Initiated: August 7, 2017 #Z-0561-2018
Product Description
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
Reason for Recall
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Details
- Recalling Firm
- Covidien LLC
- Units Affected
- N/A
- Distribution
- Nationwide including PR, Canada, China
- Location
- North Haven, CT
Frequently Asked Questions
What product was recalled? ▼
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2. Recalled by Covidien LLC. Units affected: N/A.
Why was this product recalled? ▼
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2018. Severity: Moderate. Recall number: Z-0561-2018.
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